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![NAPROXEN TABLET [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/94e84499-d536-457c-96e6-7569e8a179c4/b5beb420-bc8c-40f9-8768-4b54e858c53e-03.jpg)
![NAPROXEN TABLET [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/94e84499-d536-457c-96e6-7569e8a179c4/b5beb420-bc8c-40f9-8768-4b54e858c53e-04.jpg)
| NDC | 65841-676-01, 65841-676-10, 65841-677-01, 65841-677-05, 65841-677-10, 65841-678-01, 65841-678-05, 65841-678-10 |
| Set ID | 94e84499-d536-457c-96e6-7569e8a179c4 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA078620 |
- MEDICATION GUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NAPROXEN
naproxen tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-676 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN 250 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color YELLOW Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code ZE10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-676-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2017 2 NDC:65841-676-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078620 11/09/2017 NAPROXEN
naproxen tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-677 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN 375 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color YELLOW (yellow) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code ZE9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-677-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2017 2 NDC:65841-677-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2017 3 NDC:65841-677-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078620 11/09/2017 NAPROXEN
naproxen tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-678 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN 500 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color YELLOW Score 2 pieces Shape CAPSULE Size 16mm Flavor Imprint Code ZE8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-678-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2017 2 NDC:65841-678-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2017 3 NDC:65841-678-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078620 11/09/2017 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(65841-676, 65841-677, 65841-678) , MANUFACTURE(65841-676, 65841-677, 65841-678)
